Regulatory Affairs Specialist - Remote

About the job

We are seeking a highly motivated and detail-oriented immediate joiners Regulatory Affairs specialist to join our consulting company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally (internationally).

Responsibilities:

Submission and Approval Process:

Preparation and submission of Manufacturing License Application (MLA)

Preparation and submission of Technical/Site Transfer Applications

Preparation and submission of Marketing Authorisation Applications

Lifecycle Maintenance:

Preparation and submission of documentation for post-approval applications including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling

Compliance:

Monitor and maintain up-to-date knowledge of national, European, and International guidelines/legislation

Ensuring compliance with all regulatory processes, in readiness for both internal and external audits

Ensuring compliance with the regulations of the assigned Countries within European and International Regions

Communication:

Act as a liaison between the pharmaceutical company and the regulatory agencies

Support internal requests for information

Experience:

5-8 years of relevant experience in Regulatory Affairs Internationally

Lifecycle maintenance experience

Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling Applications

Experience working with Global Market

Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)

Good organizational skills and communication skills

Ability to prioritize and deliver high-quality work

Experience in people management/coordination is a plus

Experience in promotional/non-promotional activities is a plus

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

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